Biologicals Operations Manager — 6-Month Contract

Isilumko Staffing (JHB); Johannesburg; Presencial; ZAR 900 000 - 1 300 000; Tempo integral

Resumo da oferta

Isilumko Staffing (JHB) is assisting in recruiting for a Biologicals Manager to oversee production, QC and laboratory operations in a 6-month fixed-term contract based in Sandringham. The role ensures GLP/GMP compliance and regulatory adherence across biological products.

The ideal candidate will lead technical teams, drive process improvements and manage budgets, with 6+ years in pharmaceutical manufacturing and immunology knowledge.

Qualificações

• Four-year degree or diploma in Pharmacy or a related field.
• Registration with the relevant professional council as applicable.
• Minimum 6 years post-qualification experience in a pharmaceutical manufacturing environment, preferably biologicals.
• Experience in immunological process management.
• Working knowledge of GMP and GLP requirements.
• Experience in Quality Control testing and validation processes.
• Knowledge of Occupational Health and Safety requirements.
• Exposure to budgeting and financial management.
• Understanding of research methodologies and statistical analysis.

Responsabilidades

• Manage day-to-day activities of biologicals operations, including animal facilities and QC functions.
• Ensure production of high-quality biological products in compliance with GLP, GMP and regulatory requirements.
• Lead R&D and implementation of new technologies, testing methods, and lab processes.
• Provide technical and operational guidance for laboratory, manufacturing and immunological processes.
• Oversee quality management systems, including change controls, deviations, CAPAs, validation protocols and SOPs.
• Maintain and continuously improve quality and operational systems.
• Design and implement testing calculations, spreadsheets, specifications and SOPs.
• Liaise with regulatory and professional bodies to ensure compliance with current legislation and best practices.
• Manage relationships with suppliers, service providers and external stakeholders.
• Oversee budgets, contracts, performance and quality requirements of venom and biological material suppliers.
• Collaborate with external research institutions on product development and efficacy studies.
• Drive operational efficiency and continuous improvement initiatives within the division.

Conhecimentos

Biologicals manufacturing

Quality assurance

GMP & GLP compliance

Immunology knowledge

Microbiology knowledge

Leadership & people mgmt

Budget management

Communication skills

Analytical skills

MS Office / laboratory systems

Formação académica

Pharmacy (B.Pharm) or related degree

Descrição da oferta de emprego

Isilumko Staffing (JHB) is assisting in recruiting for a Biologicals Manager to oversee production, QC and laboratory operations in a 6-month fixed-term contract based in Sandringham. The role ensures GLP/GMP compliance and regulatory adherence across biological products.

The ideal candidate will lead technical teams, drive process improvements and manage budgets, with 6+ years in pharmaceutical manufacturing and immunology knowledge.